Sr. Clinical Engineer

Futureshaper.com; Sunnyvale (CA); Hybrid; USD 100,000 - 150,000; Full time

Job summary

An innovative company is seeking a Senior Clinical Engineer to join their dynamic team focused on advancing medical robotics. This role involves collaborating with cross-functional teams to ensure clinical safety, conducting post-market surveillance, and mentoring a team of engineers. The ideal candidate will have a strong background in medical devices, excellent communication skills, and a passion for improving patient outcomes. Join a forward-thinking organization that values diversity and offers a flexible work environment, making a significant impact in the field of robotic surgery.

Benefits

Health Insurance

401K Plan

Stock Purchase Plans

Tuition Reimbursement

Paid Time Off

Flexible Work Schedules

Qualifications

• 5-10 years experience in the medical devices industry is required.
• Strong technical experience and understanding of ISO standards.

Responsibilities

• Conduct post-market surveillance investigations and analyze complaint data.
• Collaborate with cross-functional teams to improve product design.
• Mentor a high-performing team of clinical engineers.

Skills

Medical Devices Experience

Technical Communication

Knowledge of Anatomy

Robotics Fundamentals

ISO 14971 Understanding

Problem Solving

Education

Bachelor’s Degree in Engineering or Science

Master’s Degree

Tools

Regulatory Documentation

Design Control Processes

Job description

Who We Are

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About The Team

The Senior Clinical Engineer (Post-Market) will work closely with cross-functional commercial support teams to represent clinical value propositions, clinical safety considerations, best-practice usage guidance, for patients and providers throughout the post-market activities.

A Day In The Life Of Our Sr. Clinical Engineer

• Develop internal expertise in clinical domains relevant to the company’s products
  • Understand current state of end-user and patient environment
  • Build knowledge about relevant anatomy and disease states
  • Become aware of alternative and competing treatment modalities
  • Remain current with the latest in scientific publications relevant to the company’s products
  • Attend key scientific conferences and engage with clinicians
• Conduct Post-Market Surveillance investigations related to Use Errors and Adverse Events
  • Investigate serious injury / adverse event and death complaints daily
  • Investigate potential use error complaints daily
  • Provide input to clinical conclusion to be included in the complaint reports
  • Escalate complaints that require additional review to other complaints investigation teams
  • Accurately select Risk (Hazard, Harms, Severity) for investigated complaints
• Collaborate with cross-functional teams including clinical engineering, human factors, and engineering to provide relevant clinical information related to investigated complaints to influence improvements to the design
  • Analyze complaint data to identify trends, issues, or systemic discrepancies
  • Provide feedback to engineering on potential design improvements
  • Monitor and escalate trends of complaints and system issues in the field
  • Provide the risk management input data based on real-use data from the field, required to update existing or include new failure modes into risk management files
• Collaborate with Medical Education and Sales Training teams to provide relevant clinical and use information related to complaints investigation to update training material and processes
  • Analyze complaint data to monitor and escalate trends of complaints and system issues in the field
  • Identify trends, issues, or systemic discrepancies
  • Provide feedback to Medical Education and Sales Training on training material and process improvements to improve the system usage
• Lead the development of enhanced usage techniques and potential improvements within the existing product in the field
• Support the Service and Commercial team during new customer installations and system launches
• Own the creation supporting documentation during product development for the quality system and regulatory submissions
• Plan project timelines and help clear resource dependencies allocation optimization for cross-functional projects
• Architect and oversee the pre-clinical evaluation strategy for multiple product development efforts, ensuring alignment with business objectives.
• Mentor and develop a high-performing team of clinical engineers, fostering a culture of innovation and excellence.
• Proactively identify emerging clinical technologies and assess their potential impact on the company's product strategy.
• Perform other duties as directed.

About You

• 5 to 10 years of experience in a medical devices industry
• Bachelor’s degree in Engineering or Science; Master’s degree preferred
• Strong technical experience and aptitude
• Strong understanding of ISO 14971, 21 CFR Part 820
• Ability to effectively communicate concepts, ideas, and knowledge to other individuals and teams.
• Knowledge of basic anatomy, clinical terminology, and general surgical techniques.
• Knowledge of fundamentals of robotics or electromechanical systems.
• Experience in the regulated medical device environment, including but not limited to document control processes, design control processes, protocol development, and report writing.
• Experience working with healthcare providers in a hospital environment
• Ability to travel domestically up to 25% of the time.

Pay Transparency

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range: $100,000—$150,000 USD

Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.

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